Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
AEMD NR today
The Treatment of H5N1 Avian Influenza Report: Released by Aethlon Medical
2006-03-15 16:05 ET - News Release
SAN DIEGO -- (Business Wire) -- March 15, 2006
Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in
developing therapeutic devices for infectious disease, disclosed this
afternoon that Chairman and CEO, James A. Joyce, has authored a report
entitled; The Treatment of H5N1 Avian Influenza. The content of the
report follows:
Summary
The intent of this paper is to analyze how current options for
treating H5N1 Avian Flu infection may influence the commercialization
of the Aethlon Hemopurifier(TM), a therapeutic device targeted to
modulate the immune response and capture circulating H5N1 virus. In
the face of an accelerating pandemic, the present void in effective
H5N1 treatments may dictate that the Hemopurifier(TM), initially
proposed as a treatment for drug resistant patients, evolves into an
important first-line treatment role. Mounting evidence explaining why
H5N1 is often fatal to those infected with the virus reinforces the
opportunity of the Hemopurifier(TM) as an essential weapon in the
treatment arsenal against Avian Flu.
The Threat
Scientists are increasingly worried that the H5N1 strain of Avian
Flu will mutate into a form easily passed between humans, triggering a
global pandemic. It already is unprecedented as an animal illness in
its rapid expansion, and has cost 300 million farmers more than $10
billion during its initial spread through poultry around the world.
World Health Organization (WHO) officials claim the H5N1 strain of
Avian Flu poses a greater challenge to the world than any other
infectious disease, including AIDS. WHO officials confirm that 101 of
180 people have died H5N1 infection as of March 15(h), 2006.
In the face of such dire news, researchers are unraveling the
mystery of why the H5N1 strain of the Avian Flu virus is so lethal. It
appears that H5N1 hyper-activates the immune response, a frightening
trait inherent in the worst pandemic killer known to man, the Spanish
Flu of 1918, which caused the deaths of over 40 million people. To
provide perspective, it has taken 25 years for AIDS related deaths to
rise to such levels. In the case of H5N1 infection, viral sepsis
leading to major organ failure is often the cause of death. This is
triggered when the immune system over-responds to infection by
releasing a cascade of inflammatory cells and chemicals in what is
known as a "Cytokine Storm". As a result, the likelihood of death in
individuals with robust immune systems equals or exceeds the immune
compromised who are normally most susceptible to regular seasonal flu
strains. Unfortunately, antiviral drugs are unable to shut off a
cytokine storm once it has been triggered.
Current Treatments
Antiviral drugs being stockpiled as part of a global strategy to
treat Avian Flu have no therapeutic value once the cytokine storm has
been triggered. At present, only one antiviral, oseltamivir (Tamiflu)
is known to offer some level of effectiveness against the H5N1 strain
of Avian Flu. However, Tamiflu is indicated as a treatment for normal
household varieties of influenza if administered within 48 hours of
first symptoms. The treatment window for an ultra-virulent H5N1 strain
is likely to narrow considerably. Reports already indicate the potency
of Tamiflu against the avian flu virus is reduced, even when taken
after 24 hours of the first symptoms of the disease. H5N1 resistance
to Tamiflu is already being reported in Southeast Asia.
Prolonged incubation combined with a short antiviral treatment
window also concerns researchers. Dr. Tim Uyeki, a medical
epidemiologist with the influenza branch of the Centers for Disease
Control and Prevention (CDC) quoted the following to the Wall Street
Journal; "Patients aren't presenting (symptoms) early in the illness.
If the cytokine storm has already been triggered, antiviral drugs
aren't going to turn it off."
A successful global strategy against H5N1 will, at a minimum, have
to rely on therapeutics that can modulate the overproduction of
cytokines. The March 2, 2006 issue of The Lancet reported that
researchers at the well-regarded Karolinska Institute in Stockholm are
proposing the use of chemotherapy to kill off excess immune cells as a
means to curb the cytokine storm leading to viral sepsis in H5N1
patients. While the concept may seem radical, researchers are likely
to agree that any treatment able to damp down the immune system might
be helpful. Unfortunately, taming the immune system without destroying
defenses against infection has yet to be demonstrated with drugs.
Until other treatments surface, health officials from the United
States and other nations continue a strategy of stockpiling Tamiflu.
To date, the Department of Health and Human Services (HHS) has ordered
12.4 million doses of Tamiflu, and expects to have a stockpile of 20
million doses by the end of 2006. Adjunctive antiviral therapies able
to increase Tamiflu effectiveness will need to surface if these
stockpiles are to offer any hope of widespread benefit. Regardless,
the effectiveness of Tamiflu and other antiviral drugs ends once the
cytokine cascade is triggered.
The Hemopurifier(TM) to Treat Avian Flu
The Hemopurifier(TM) is presently the only proposed treatment for
H5N1 Avian Flu that simultaneously targets the clearance of H5N1 and
the modulation of the cytokine storm. The deployment of the
Hemopurifier(TM) as a treatment for Avian Flu is consistent with a
corporate strategy to evolve the Hemopurifier as a broad-spectrum
treatment for drug and vaccine resistant pathogens. In this context,
the Hemopurifier(TM) was recently awarded the 2006 Technology
Innovation Award by global industry researcher, Frost & Sullivan.
Specific to H5N1 infection, the Hemopurifier(TM) represents a novel
extracorporeal method to mimic and boost the immune response, which
should improve the effectiveness of antiviral drugs when deployed as
an adjunctive therapy. Once a cytokine storm has been triggered, the
Hemopurifier could serve as the first and perhaps only option for
treating H5N1 infected patients. Attributes and considerations for
deploying the Hemopurifier(TM) as a treatment for pandemic flu,
include:
-0-
*T
1. Rapid Clearance of H5N1 - The affinity agents immobilized
within the Hemopurifier(TM) have broad-spectrum capabilities to
capture envelope viruses by binding to glycosolated proteins
that reside on their surface. In the case of H5N1, the virus
capture is directed at two major surface glycoproteins, the
hemagglutinin (HA) and neuraminidase (NA), which are available
binding sites, even in the case of viral mutation. As compared
to normal influenza, longer periods of incubation and
accessibility to circulating virus appear to be the norm in
H5N1 infection. The ability to clear H5N1 virus and viral
fragments prior to cell and organ infection, would decrease
cytokine production, inhibit disease progression, and improve
the effectiveness of Tamiflu and other antiviral drugs.
2. Broad Clearance of Cytokines - The structure of the
Hemopurifier(TM) vastly improves the potential to clear the
full spectrum of deleterious cytokines, as compared to
Hemofiltration techniques indicated as an adjunct treatment for
cytokine induced sepsis since 1990. In fact, the
Hemopurifier(TM) may be an ideal method to modulate cytokine
production, as the pores of the Hemopurifier(TM) fibers are
large enough to allow both cytokines and cytokine aggregates,
unable to be cleared in Hemofiltration, to be separated and
captured from circulation. Non-human studies to document the
capture of cytokines, prevalent in autopsy reports of H5N1
induced deaths, have been initiated by Aethlon researchers.
3. Expedited Regulatory Path - Under the Bioterrorism Act of 2002,
pandemic flu therapies can be developed and financed by the
Project BioShield Act. The guidelines require clinical trials
to only demonstrate safety in man, as traditional efficacy
studies are not plausible or ethical in the case with
pathogenic influenza. Thus, the FDA is permitted to accept
efficacy data from animal models related to drug and vaccine
submissions. In the absence of an animal model, the
Hemopurifier(TM) is positioned to demonstrate the capture of
viruses and cytokines from human blood through closed loop
studies that replicate human treatment. An Avian Flu Industry
Report published by Griffin Securities, suggests that these
regulatory provisions not only provide an accelerated path to
approval, but could also provide government funding for
stockpiling, representing large commercial opportunities for
companies developing Avian Flu therapies.
4. Human Safety Observations - H5N1 Avian Flu is not a call to
arms to initiate drug and vaccine research programs. It's a
siren to deliver therapeutics that are in late stage
development and can be delivered to market. The proposed
treatment of H5N1 with the Aethlon Hemopurifier(TM) would be
based on treatment protocols already established in a human
safety study currently being administered to renal failure
patients co-infected with the Hepatitis-C virus. To date, no
material adverse events have been observed in these patients.
Upon completion of this study, Aethlon will submit the safety
data as part of regulatory submissions to the Food and Drug
Administration (FDA) in an effort to pursue the treatment of
H5N1 Avian Flu and other drug and vaccine resistant viral
conditions. The Company may also seek to commercialize the
Hemopurifier(TM) through regulatory agencies outside of the
United States.
*T
In closing, the ominous threat of an H5N1 pandemic; the absence of
a vaccine; an evolving resistance to a single drug option; and, a
post-infection immune response that triggers a highly fatal cytokine
storm; provides organizations with innovative therapeutics, the
opportunity to demonstrate effectiveness on a global stage. Those who
execute and deliver therapeutics to the market will play an important
role in saving the lives of individuals infected with H5N1 pandemic
influenza.
About Aethlon Medical
Aethlon Medical is developing the first medical device to treat
infectious disease. The device, known as the Hemopurifier(TM), is a
broad-spectrum treatment countermeasure against drug and vaccine
resistant bioweapons, naturally evolving pandemic threats such as H5N1
Avian Flu, and chronic infectious disease targets including
Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Aethlon
has also initiated research on a second generation Hemopurifier(TM)
that targets the capture of growth factors inherent in the spread of
Cancer. More information on Aethlon Medical and the Hemopurifier(TM)
technology can be found at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and
involve risks and uncertainties. Such forward-looking statements
involve assumptions, known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievements of Aethlon Medical, Inc to be materially different from
any future results, performance, or achievements expressed or implied
by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the Company's ability to
raise capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of its
products, the Company's ability to manufacture its products and
provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability
exposure, uncertainty of market acceptance, competition, technological
change, and other risk factors. In such instances, actual results
could differ materially as a result of a variety of factors, including
the risks associated with the effect of changing economic conditions
and other risk factors detailed in the Company's Securities and
Exchange Commission filings.
Contacts:
Aethlon Medical, Inc.
Jeff Richardson, 858-459-7800 x302
jrichardson@aethlonmedical.com
or
James A. Joyce, 858-459-7800 x301
jj@aethlonmedical.com
GNBT NR today
Generex Biotechnology to Present Its Avian Influenza Vaccine Program at DNA Forum in London
2006-03-14 08:30 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/14/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=113081&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology at Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, will present the Antigen Express H5N1 avian influenza vaccine program at the upcoming Third Annual DNA Vaccines Forum to be held in London, UK, March 17 - 18, 2006.
The strategy employed by Antigen Express focusing on the development of its novel H5N1 avian influenza vaccine utilizes small portions of the H5 protein that are modified to enhance antigen-specific stimulation of T-helper cells. Upon infection, such T-helper cell responses enhance the speed and strength of neutralizing antibody production. It is anticipated that the vaccine being developed will both impart some level of protection on its own and enhance the activity of other types of avian influenza vaccines, including DNA vaccines.
The meeting will focus on the latest advances involving DNA vaccine technology as well as clinical experiences and regulatory issues. All vaccines that are currently approved for human use are inactivated or attenuated (weakened) viruses or recombinant protein vaccines. DNA vaccines are a promising new approach with the potential to prevent many infectious diseases such as H5N1 influenza, anthrax and plague. Although a number of DNA vaccines are currently in clinical trials, none have been approved for use in humans. One of the challenges facing the use of DNA vaccines is that the responses generated in humans may be insufficient to prevent infection. To address this issue, scientists have investigated numerous methods to enhance the immunogenicity of DNA vaccines including the use of novel adjuvants and cytokines. For many diseases, including influenza, the generation of neutralizing antibodies produced by B lymphocytes is sufficient to protect against infection. The CD4 T cell response is essential for generating high levels of neutralizing antibodies in addition to eliciting memory T and B cell responses that provide protection against future infections. CD4 T cells recognize MHC class II epitopes presented on the surface of antigen presenting cells. Dr. Douglas Powell and Dr. John Zinckgraf at Antigen Express have demonstrated that immunization of mice with MHC class II epitopes derived from the H5N1 influenza hemagglutinin protein coupled to the proprietary Ii-Key peptide greatly enhances the CD4 T cell responses to a DNA vaccine encoding the H5N1 influenza hemagglutinin protein and may be used as a strategy to increase the immunogenicity of DNA vaccines.
One of the major challenges facing immunization with many of the currently available vaccines is the need for refrigeration, often referred to as maintenance of the cold chain. This is a particularly difficult problem in developing countries with limited medical resources. One of the advantages of a vaccine utilizing peptides and DNA is that both of these components can be lyophilized, stored at ambient temperatures and reconstituted "on-site" with saline. "We have promising data in an animal model suggesting that we will be able to achieve levels of immunity consistent with protection from H5N1," said Dr. Powell. The company has recently completed a pre-IND meeting with the FDA and hopes to enter human clinical trials of its peptide vaccine against H5N1 later this year.
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.
For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
VAS-T NR today 84m at 2.69
FP/wire say Vasogen holders take hike after test fails
2006-03-14 08:52 ET - In the News
The Financial Post reports in a Bloomberg dispatch Tuesday shares of Vasogen plunged Monday. The unbylined item says the hit came on news its Celacade therapy for treating inflammation failed to help patients with an artery disease walk farther in a treadmill test. Shares on the Toronto Stock Exchange were down 86 cents to $2.69 on volume of 1.2 million shares. The trial of 553 patients with peripheral artery disease missed its main goal of bolstering endurance. The technology did succeed in "significantly" reducing levels of high sensitivity C-reactive protein (hs-CRP), a substance tied to the risk of heart failure, stroke and heart attacks. "The ability to impact hs-CRP levels represents an exciting new feature of our technology," David Elsley, chief executive officer, said in a statement. The stock was already well down in the 12 months preceding Monday's announcement. Monday's decline is the biggest since Aug. 30, 2005, when shares fell nearly half after Vasogen said Celacade did not work against hardening of the arteries. Nigel deGruyther, a health-care analyst at Toronto-based Research Capital, rates the shares a "speculative buy" and does not own any.
Here is a daily 3 month chart of MPH-T
DJE-V is getting set for another run
U308 to 40.00/lb up .75 from last week - Sweet.
Looking at VME-V, DJE-V up .05 to 1.45 today. Nice.
Great chart. They will do well IMHO.
VAS-T NR today 84m at 3.55
Vasogen Celacade phase III does not meet end point
2006-03-13 05:53 ET - News Release
Mr. Glenn Neumann reports
VASOGEN ANNOUNCES RESULTS FROM PHASE III Simpadico TRIAL IN PERIPHERAL ARTERIAL DISEASE - STUDY DID NOT MEET PRIMARY ENDPOINT - - CELACADE SIGNIFICANTLY REDUCED C-REACTIVE PROTEIN, A WIDELY RECOGNIZED MARKER OF SYSTEMIC INFLAMMATION AND CARDIOVASCULAR RISK -
Vasogen Inc. has released the results from the 553-patient phase III Simpadico trial of its Celacade technology (Celacade) in peripheral arterial disease (PAD). While the Simpadico study did not reach the primary end point of change in maximal treadmill walking distance, Celacade significantly reduced high sensitivity C-reactive protein (hs-CRP), a prespecified end point and a widely recognized marker of systemic inflammation associated with increased cardiovascular risk, including heart failure, stroke and heart attack.
The results are being presented today at a late-breaking clinical trial session of the 55th annual scientific session of the American College of Cardiology in Atlanta, by Dr. Jeffrey Olin, professor of medicine at the Mount Sinai School of Medicine, director of vascular medicine at the Zena and Michael A. Wiener Cardiovascular Institute in New York, and principal investigator and chairman of the steering committee for the Simpadico trial.
"We are obviously disappointed that Celacade was not shown to improve walking distance in PAD, one of the most difficult end points in which to demonstrate a therapeutic benefit," stated Dr. Olin. "It is very interesting to note, however, the finding of a significant reduction in C-reactive protein, a well-recognized inflammatory marker that is associated with increased risk of cardiovascular events. Given this finding, and the fact that otherwise successful therapies have failed to demonstrate a walking distance improvement in PAD, I look forward to the results of the ongoing trial of Celacade in chronic heart failure, where inflammation plays an important role."
Measurement of hs-CRP was included in Simpadico as a prespecified endpoint to assess the impact of Celacade on systemic inflammation. The mean levels of hs-CRP at baseline were well matched at 4.15 milligrams per litre and 4.81 milligrams per litre in the placebo, and Celacade groups, respectively, and these levels are consistent with a patient population at moderate-to-high risk for cardiovascular and PAD events. Mean hs-CRP was reduced by 0.93 milligram per litre in the Celacade group, while it increased by 0.50 milligram per litre in the placebo group (p equals 0.008, placebo versus Celacade, baseline to end of study). A majority of patients were on antiplatelet therapy (82.1 per cent placebo, 77.5 per cent Celacade), predominantly aspirin, and were receiving lipid-lowering therapy (81.3 per cent placebo, 79.8 per cent Celacade), predominantly statins, which are known to reduce hs-CRP levels in cardiovascular conditions, providing evidence that Celacade significantly reduces hs-CRP levels on top of anti-inflammatory pharmaceuticals.
"The high sensitivity C-reactive protein results from the Simpadico study provide compelling evidence that our Celacade technology produces a significant anti-inflammatory effect," said Dr. Jay Kleiman, chief medical officer and head of cardiovascular development for Vasogen. "Although Celacade did not improve walking distance in this study, the clinically significant reduction of a recognized inflammatory marker that is linked to cardiovascular disease risk has important implications for chronic heart failure and other cardiovascular conditions."
The Simpadico study screened 947 patients and randomized 553 subjects. The modified intention-to-treat (mITT) population (n equals 535) that was used for primary data analysis consisted of all patients randomized who received at least one study treatment and had at least one postrandomization treadmill test. The placebo (n equals 273) and Celacade (n equals 262) groups were well balanced for all important baseline characteristics, including demographics, maximal treadmill walking distance (absolute claudication distance, ACD; 321 metres placebo, 303 metres Celacade), smoking history, concomitant medical conditions and medications.
The percentage increase in ACD between baseline and 26 weeks in the mITT group (the primary end point) was not significantly different between Celacade and placebo groups. Similarly, there were no significant differences in the pain-free treadmill walking distance (initial claudication distance, ICD) between the two groups.
The study was also designed to investigate the impact of Celacade on additional prespecified end points, including PAD-related and cardiovascular outcome events. In a time-to-first-event analysis, 84 patients experienced a PAD-related or cardiovascular outcome event during the course of the study, 46 in the placebo group and 38 in the Celacade group. In a similar analysis of only PAD-related outcome events, 20 patients experienced an event, 14 in the placebo group and 6 in the Celacade group. Fifteen of these patients progressed to critical limb ischemia, 12 in the placebo group and 3 in the Celacade group (p equals 0.03).
While changes in quality of life and ankle-brachial index (ABI) did not reach significance in the mITT group, exploratory analysis in the per-protocol group (patients with no major protocol violations and who received a predesignated number of treatments, n equals 416), showed significant changes in several of these measures. Quality-of-life analysis (SF-36, v2), showed a significant difference between Celacade and placebo in the physical functioning (p equals 0.03) and Social Functioning (p equals 0.05) Scores. On the walking impairment questionnaire (WIQ), Celacade was also associated with significant improvements in the distance (p equals 0.02) and Speed (p equals 0.03) domains. There was also a small, but statistically, significant (p equals 0.04) improvement in ABI at 26 weeks in the Celacade group.
Celacade was shown to be well tolerated in this patient population, who were receiving standard-of-care medications for atherosclerosis and PAD, including statins, beta-blockers, anti-platelet agents and ACE-inhibitors. As previously reported in Stockwatch, study treatments were terminated early, based on a recommendation by the study's external safety and efficacy monitoring committee, due to an absence of a sufficiently strong efficacy signal and an observation of an imbalance in the distribution of malignancy cases. An independent review of these cases was conducted at study end by a recognized expert in medical oncology who was not aware of treatment group allocations (blinded). This review concluded that the number and types of malignancies identified in both study arms were consistent with that expected in the study population (18 expected, 40 per cent lung), which is known to be at higher risk for developing malignancy (91 per cent current or ex-smokers, mean age of 67 and predominantly male). The review also confirmed that, although there was no formal screening at baseline for malignancy, there was evidence that indicates a clear prestudy diagnosis of malignancy in eight cases (one placebo, seven Celacade) leaving 10 cases (two placebo, eight Celacade); a distribution that was not statistically different. Of note, the data and safety monitoring board for the recently completed ACCLAIM trial of Celacade involving 2,400 patients has conducted regular reviews and has not expressed any concerns regarding safety.
"The ability to impact hs-CRP levels represents an exciting new feature of our technology, and I look forward with increased enthusiasm to the results from our ACCLAIM trial in heart failure, and to exploring new areas in cardiovascular disease," stated David Elsley, president and chief executive officer of Vasogen. "I would like to thank Dr. Jeff Olin and the members of the steering committee, the central end points committee, the external safety and efficacy monitoring committee, and the clinical investigators for their considerable efforts in the Simpadico program. Most importantly, I thank the patients, without whose dedicated participation in clinical research, no medical advances would be possible."
PTI-T NR today 92m at 6.72
Globe/CP say Patheon brass roasted by angry holders
2006-03-10 08:26 ET - In the News
The Globe and Mail reports in a Canadian Press dispatch Friday executives of Patheon outlined plans to turn around the troubled drug maker at its annual meeting Thursday, but that did not prevent questions from angry shareholders. The unbylined item says last week, the Mississauga-based company reported its first quarterly loss since its inception in 1974. At the meeting, executives said they intend to cut costs, bring in new business and improve efficiency. But some shareholders were not convinced. They hammered chief executive officer Robert Tedford and other executives with questions about Patheon's sliding stock price. They also wanted to know more about the company's Puerto Rican purchase, operational issues at its Canadian plants, and disclosure. "Right now, we're in a period in which we're not getting the growth which we expected. The business doesn't always go up in a straight line," Mr. Tedford said. "Yeah, but yours is going straight down," a shareholder countered. This was one of a handful of heated exchanges. Patheon shres fell eight cents to $6.72 on the Toronto Stock Exchange.
Here's one for you DJE-V
I like this one
This one looks ready DJE-V
Web address of WHO - Avian flu:
http://www.who.int/csr/disease/avian_influenza/en/
PTI-T NR today 92m at 6.80
Globe says Corus, others get greedy with stock options
2006-03-09 08:22 ET - In the News
See In the News (C-CJR) Corus Entertainment Inc
The Globe and Mail reports in its Thursday, March 9, edition that Corus Entertainment executive chairwoman Heather Shaw earned $1.5-million with Corus stock options 18 months ago. The Globe's Derek DeCloet, in the Vox column, writes that investors who bought shares five years ago, just after the Nelvana deal, have not made a cent. Mr. DeCloet is not meaning to single out Ms. Shaw, but is merely showing "the absurdity of granting stock options with no strings attached." For instance, he calculates that if Corus shares rise five cents a year, the value of Ms. Shaw's options tops $3.1-million by March, 2012. Warren Buffett was right when he said fixed-price options are "a royalty on the passage of time." If an executive in a stagnant company has options that expire in 10 years, he will make a bundle as long as the company buys back shares. Mr. Buffett says good companies should grant options with strike prices adjusted for retained earnings. Mr. DeCloet points out that Onex, Biovail, Patheon, Cott and CanWest Global are all prolific stock options issuers
08/03/2006 (15:44) Reuters
Belgian treated for bird flu symptoms in Brussels
BRUSSELS, March 8, (Reuters) - A Belgian man who returned from China on March 5 has been admitted to hospital with the symptoms of bird flu, news agency Belga quoted the health minister as saying on Wednesday.
A Belgian official from the country's health agency told Belga it was a possible case of bird flu rather than a probable one.
MS-T NR today 62m at 3.46
Globe says BioMS may be on tail of MS treatment
2006-03-08 08:58 ET - In the News
The Globe and Mail reports in its Wednesday, March 8, edition that BioMS Medical has revealed impressive phase II trial results for its multiple sclerosis treatment. The Globe's Omar El Akkad writes that BioMS may gain access to an untapped health care market worth about $8-billion. The phase II trial shows BioMS's drug, MBP8298, slows the progression of MS for five years in later-stage patients with two common immune response genes. About three-quarters of MS patients have those genes. The trial involved a two-year treatment and five-year follow-up on 20 patients. The University of Alberta and BioMS analyzed the results. Rodman & Renshaw analyst Elemer Piros says the delay in progression of MS is very notable. Usually, an MS patient will reach paraplegia in 25 years. Chairman Clifford Giese founded BioMS when his MS struck his wife. The company has the only phase III trial of a secondary progressive MS treatment in the world. Nearly half of MS patients suffer from secondary progressive MS. Management says, if phase III is as positive as phase II, BioMS will seek regulatory approval for MBP8298 by late 2008. BioMS shares jumped to $3.46 on the Toronto Stock Exchange on March 7.
GNBT NR todat 2.02
Generex Biotechnology Announces Positive Preliminary Results in a Long-Term Clinical Trial of Generex Oral-lyn(TM) in Juvenile Patients With Type-1 Diabetes Mellitus (DM)
2006-03-08 08:45 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/08/06
http://media.marketwire.com/attachments/200603/MOD-248856_JuvenilestrialMar06Chart1.jpghttp://media.marketwire.com/attachments/200603/TN-248857_JuvenilestrialMar06Chart2.jpghttp://media.marketwire.com/attachments/200603/MOD-248857_JuvenilestrialMar06Chart2.jpghttp://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=112475&ProfileId=051205&sourceType=1" target="_blank">http://media.marketwire.com/attachments/200603/TN-248856_JuvenilestrialMar06Chart1.jpghttp://media.m...
Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today positive preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in juvenile patients with Type-1 diabetes mellitus (DM).
Generex previously reported the successful replacement, during a 12-day period, of subcutaneously (s.c.) injected pre-prandial regular insulin with Generex Oral-lyn in 10 adult patients with Type-1 DM. The objective of this new study is to document the effects of replacing the lunchtime dose of s.c. injected regular insulin with Generex Oral-lyn in juvenile type-1 DM patients. A comparison between the two different insulin preparations was done initially (3-4 weeks), followed by a six month replacement period with Generex Oral-Lyn at lunchtime. The results of the first ten weeks of the trial are referenced here. As in the previous study, this new study involves a Generex Oral-lyn split-dose treatment, i.e. the application of Generex Oral-lyn spray both before and after each meal. Generex believes that this approach offers a new diabetes treatment paradigm by offering improved efficacy (as Generex Oral-lyn is better at mimicking the healthy body's natural insulin production) and patient compliance (no painful injections) resulting in greater metabolic stability thereby better controlling diabetes and reducing the complications associated with it. Treatment of adolescents with Type-1 DM is challenging and Generex chose to replace the lunchtime dose because it is this dose that is most frequently associated with non-compliance.
This new study is taking place at the Institute of Endocrinology IEMYR in Quito, Ecuador, under the supervision of Dr. Jaime Guevara-Aguirre M.D., the principal Investigator of the study. All of the participants in the study were referred to IEMYR for treatment. The participants are: (a) 24 adolescents (12 males, 12 females) with a mean age of 14.7 years and a mean Body Mass Index (BMI) of 21.7, and (b) five young adults (two males, three females) with a mean age of 20.6 years and a mean BMI of 23.0. The mean age of the entire participant group is 15.7 years and the mean duration of the diabetes mellitus is 6.8 years.
Because the study participants were referred to IEMYR in varying states of diabetic control, it was necessary to metabolically stabilize them using standardized therapy prior to the commencement of the study. Upon referral to IEMYR, each participant received a schedule of baseline insulin glargine in addition to thrice-daily pre-prandial injections of regular insulin. Metabolic stability was achieved by intense monitoring of glucose levels, adjustments to the insulin schedule, and implementation of proper dietary measures. Glucose was monitored frequently (six-point glucose daily profiles for 20 days). Fructosamine and glycosylated hemoglobin (HbA1c) were obtained at the commencement of the stabilization program and after 20 days.
The 29 subjects (2 new subjects were incorporated shortly after the commencement of the study) were metabolically stabilized in a very short period of time (20 days) as documented by important and statistically significant improvements in the six-point daily glucose profiles (p < 0.0005), as well as in protein glycosylation parameters: Fructosamine (p < 0.0001), and HbA1c (p < 0.0001). The decrement in the last two parameters displayed strong correlation. These results were attributed to the improvement in previous insulin schedules, enhanced nutritional advice, and intense glucose monitoring.
After stabilization and an initial four weeks with regular insulin at lunchtime, Generex Oral-lyn replaced the lunchtime injected insulin. The following 10-week results were obtained:
Stabilization Phase s.c. Regular Generex
Insulin Phase Oral-lyn Phase
N Mean SD N Mean SD N Mean SD
27 172.1 75.2 27 172.1 75.2 29 140.4 35.5
27 139.7 50.1 29 140.4 35.5 29 143.3 39.9
Change -32.4 -31.7 2.9
< .0005 < .0001 p =
0.490
The investigators concluded that during the first two and one-half months of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with Type-1 DM was associated with overall adequate glycemic control and similar fructosamine and glycosylated hemoglobin (HbA1c) concentrations.
Generex believes that Generex Oral-lyn can make a significant contribution to the achievement and maintenance of metabolic stabilization by providing a safe, simple, fast, effective, flexible, and familiar alternative to pre-prandial insulin injections. As a pain-free and convenient method of insulin delivery, Generex Oral-lyn will allow individual patients to "fine tune" and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn provides the opportunity for the establishment of a new and more effective diabetes treatment paradigm.
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Image Available: http://www.marketwire.com/mw/frame_mw?attachid=245211
Image Available: http://www.marketwire.com/mw/frame_mw?attachid=245214
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
Nice link.
Thanks JW
AEMD NR today .47
Aethlon Medical To Provide Corporate Update at the North America Investing & Partnering in Biotech Conference
2006-03-07 13:30 ET - News Release
SAN DIEGO -- (Business Wire) -- March 7, 2006
Aethlon Medical, Inc., (OTCBB:AEMD) a pioneer in
developing therapeutic devices for infectious disease, announced today
that its Chairman and CEO, James A. Joyce, will provide a corporate
update on March 13th at the North America Forum for Investing &
Partnering in Biotech and Medtech Conference. The venue for the
conference is the Fairmont Copley Plaza Hotel in Boston,
Massachusetts. Mr. Joyce's presentation is scheduled to begin at
4:20pm EST. A "live" web-cast link to the presentation will be
disclosed in a separate news release prior to the conference.
Additional conference details can be accessed at
www.sachsforum.com/boston06.html.
About Aethlon Medical
Aethlon Medical is developing the first medical device to treat
infectious disease. The device, known as the Hemopurifier(TM), is a
broad-spectrum treatment countermeasure against drug and vaccine
resistant bioweapons, naturally evolving pandemic threats such as H5N1
Avian Flu, and chronic infectious disease targets including
Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). More
information on Aethlon Medical and the Hemopurifier(TM) technology can
be found at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and
involve risks and uncertainties. Such forward-looking statements
involve assumptions, known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievements of Aethlon Medical, Inc to be materially different from
any future results, performance, or achievements expressed or implied
by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the Company's ability to
raise capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of its
products, the Company's ability to manufacture its products and
provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability
exposure, uncertainty of market acceptance, competition, technological
change, and other risk factors. In such instances, actual results
could differ materially as a result of a variety of factors, including
the risks associated with the effect of changing economic conditions
and other risk factors detailed in the Company's Securities and
Exchange Commission filings.
Contacts:
Aethlon Medical, Inc.
Jeff Richardson, 858.459.7800 x302
jrichardson@aethlonmedical.com
James A. Joyce, 858.459.7800 x301
jj@aethlonmedical.com
GNBT NR today 2.24
Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn(TM)
2006-03-03 08:45 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/03/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=111920&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product for the treatment of diabetes.
The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn(TM) with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn(TM) to be marketed and distributed in Canada.
"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn(TM) and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."
The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex website at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800)391-6755 and (416)364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212)732-4300
NVAX NR today 5.77
Novavax and Bharat Biotech Announce Strategic Alliance for Pandemic Influenza Vaccine Development
2006-03-06 07:00 ET - News Release
HYDERABAD, India and MALVERN, Pa., March 6 /PRNewswire-FirstCall/ -- Novavax, Inc. and Bharat Biotech International Limited (BBIL), today jointly announced a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund 100% of the pre-clinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all pre-clinical and clinical data generated by BBIL and will receive a double digit royalty on all future sales located within BBIL's geographic territories.
Cases of avian influenza (Bird Flu) in poultry and humans have been occurring sporadically throughout the world, prompting the World Health Organization to call avian flu the greatest concern to human health. There are at least 16 Hemagglutinin and 9 Neuraminidase genes within various subtypes of influenza viruses known to circulate in wild waterfowl, each with the potential to infect and cause severe disease in poultry and humans. Three avian influenza subtypes (H9N2, H7N7, and H5N1) have transmitted to humans in recent years and are considered major threats for a pandemic outbreak.
Novavax's Virus-Like Particle Vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the Hepatitis B vaccine. In addition, the developmental Human Papilloma Virus vaccines are also based on VLP technology. This is the first time that VLP technology has been applied to create an influenza virus vaccine. The technology is a particularly good fit for addressing pandemic influenza because it obviates the reliance on the supply of embryonated eggs for the production of the vaccine. Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine (See Press Releases dated September 13, 2005 and February 28, 2006). In addition, this technology can be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.
Commenting on the agreement, Dr. M.K. Bhan, Secretary, Department of Biotechnology, Government of India said, "This is a very positive development. In the spirit of combining global expertise to collectively combat the threat posed by the rapidly spreading avian influenza virus, the department of biotechnology and the Government of India stand ready to provide all enabling support to ensure the success of this partnership between Novavax and BBIL".
Dr. Rahul Singhvi, President and CEO of Novavax said, "We are delighted that BBIL has chosen Novavax's VLP and Novasome(R) adjuvant technologies to develop, produce, and distribute a vaccine against H5N1 and other strains of avian influenza for the Indian population. BBIL has established itself as a leader in adopting innovative vaccine technologies as evidenced by their collaborations with Wyeth and Acambis. We believe that by leveraging the clinical, process and manufacturing capabilities of BBIL, we will be able to expedite the development and regulatory approval of our VLP-based pandemic influenza vaccines around the world".
Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech International Ltd, said "We are extremely pleased to announce this unique partnership between Novavax and BBIL, with the guidance and support of the Department of Biotechnology, Government of India. This agreement between our companies is bigger than just business. It is an attempt to bring together capabilities of two different organizations across the world to address the global public health and economic threat posed by pandemic influenza. Novavax's VLP technology is clearly one of the most effective in addressing emerging strains of the virus and BBIL's proven capabilities in process development, clinical development, and manufacturing infrastructure will help expedite the availability of a VLP-based vaccine for pandemic influenza to the Indian public and the world at large. By joining hands with Novavax, BBIL would be making, in a modest way, its contribution to the cause of Public Health in India and the Developing World".
This alliance will be overseen by a Steering Committee chaired by Dr. Richard Klausner, eminent scientist and Former Executive Director of the Bill and Melinda Gates Foundation and Former Director of the US National Cancer Institute. Dr. Klausner is a special advisor to both the Government of India and to Novavax, Inc. Commenting on this agreement, Dr. Klausner said "I am heartened by this partnership between Novavax and BBIL. I have had a chance to work with each of these organizations and I know the principals in both firms well. These organizations and their management teams are serious in their commitment and are uniquely suited to develop a vaccine against pandemic influenza. I am confident that by combining their mutual capabilities and by working closely with the Department of Biotechnology, Government of India, they will be more effective in arriving at a solution for the good of public health worldwide".
About Virus-Like Particle (VLP) Technology
Novavax's VLP vaccine technology utilizes recombinant DNA to present components of the influenza virus in three-dimensional virus-like structures optimized to elicit a protective immune response without the risk of infection and without the addition of chemical adjuvants. Using the proprietary process associated with this VLP technology, Novavax intends to further develop vaccines which can be produced aseptically, thereby reducing contamination risk, while achieving high, cost-effective yields.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The Company's platforms include the virus-like particle manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimers. The Company is developing vaccines against the H5N1 and other strains of avian influenza and human seasonal influenza viruses using its VLPs and Novasomes. Novavax's drug delivery platforms include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, Estrasorb(R). In addition to MNP, Novavax drug delivery technologies include Novasomes (paucillamellar non-phospholipid vesicles) and Sterisomes(R) (subcutaneous depot injection). The company has several products utilizing the MNP technology in various stages of development.
About Bharat Biotech International Inc.
Bharat Biotech International Limited based in Hyderabad, India, is a privately held, multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat's state-of-the-art manufacturing plant is the largest of its kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved by Korean Food & Drugs Administration (KFDA), it sprawls over a picturesque campus at Genome Valley, Hyderabad. Built with an investment of over INR 1000 million, the facility's manufacturing, control procedures and protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA, and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2004 and quarterly reports on Form 10Q for the quarters ended March 31, 2005 and June 30, 2005 and September 30, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax Inc.,
+1-484-913-1213, khamilton@novavax.com; or Dr. V. Krishna Mohan, President
of Bharat Biotech International Inc, +91-40-2348-0567,
kmohan@bharatbiotech.com
Web site: http://www.novavax.com//
QLT.T NR today 91m at 8.38
QLT Eligard injunction stays put for now
2006-03-07 05:12 ET - News Release
Ms. Tamara Hicks reports
QLT UPDATES ON THE U.S. ELIGARD(R) PATENT LITIGATION; TEMPORARY SUSPENSION OF ELIGARD SALES IN THE U.S. BY SANOFI-SYNTHELABO
The Court of Appeal has informed QLT Inc.'s subsidiary, QLT USA Inc., that the injunction against promoting, manufacturing, selling and offering for sale Eligard has been stayed pending its decision to grant a permanent stay of the injunction. Also, QLT USA's marketing partner for Eligard in the United States, Sanofi-Synthelabo Inc., has advised QLT USA that it is suspending sales of Eligard in the United States until the expiry of TAP Inc.'s patent, United States patent No. 4,728,721, on May 1, 2006.
As mentioned in QLT's news issued in Stockwatch on Feb. 22, 2006, Sanofi-Synthelabo informed QLT USA that, unless the court explicitly permits the continued sale of Eligard, or a licence is granted, it may elect to suspend Eligard sales in the United States until the '721 patent expires.
On Feb. 27, 2006, the United States District Court for the Northern District of Illinois Eastern Division granted an injunction enjoining QLT, Sanofi-aventis and their subsidiaries from promoting, manufacturing, selling and offering for sale QLT USA's Eligard product in the United States until the '721 patent expires on May 1, 2006.
QLT USA and Sanofi-Synthelabo intend to continue to vigorously defend this case, and to seek an appeal of the adverse judgment in the Court of Appeals.
We seek Safe Harbor.
Good chart. Sage feel free to post updates. Thanks.
I've noticed that we often have an up day in the medicals when everything else is down LOL Good for my pf.
ISM.v Good NR today. Should make it throu .60 to blue sky country:
Inspiration confirms historical results at Langmuir
2006-03-06 10:36 ET - News Release
Mr. Randy Miller reports
INSPIRATION INTERSECTS 27.83 METRES OF 2.024% NICKEL WITH ASSAYS UP TO 7.361% NICKEL OVER 1.25 METRES
Inspiration Mining Corp. has released the results of the continuation of its diamond drilling program on its Langmuir project, located in Langmuir township south of Timmins, Ont. The Langmuir property consists of 69 unpatented contiguous mining claim units covering approximately 1,090 hectares in the north-central portion of Langmuir township, Porcupine mining division, district of Cochrane, Ont. The property is approximately 25 kilometres southeast of Timmins, Ont., and hosts the past-producing Langmuir No. 1 mine, and majority of the past-producing Langmuir No. 2 mine.
The following assay results of drill hole L105-1 at the former Langmuir No. 1 mine have been received, compiled and condensed to the following:
Drill From To Core
hole Zone (m) (m) length
(m)
L105-1 Z1 75.00 78.24 3.24
Z2 90.00 102.00 12.00
contains 95.98 99.38 3.40
Z3 108.40 136.23 27.83
or 123.33 136.23 12.90
contains Z3-A 123.33 128.71 5.38
Z3-B 128.71 132.29 3.58
with 131.70 132.29 0.59
Z3-C 132.29 134.36 2.07
with 132.67 133.36 0.69
Z3-D 134.36 136.23 1.87
with 134.36 135.61 1.25
Drill True Weighted
hole Zone width average
(m) (%)
L105-1 Z1 2.74 0.610
Z2 10.54 0.434
contains 2.99 0.845
Z3 19.25 2.024
or 8.91 3.863
contains Z3-A 3.78 2.658
Z3-B 2.45 5.483
with 0.40 6.080
Z3-C 1.46 2.405
with 0.49 4.080
Z3-D 1.27 5.843
with 0.85 7.361
Drill hole L105-1 was drilled on at azimuth north 304 degrees east with collar dips of minus 55 degrees at co-ordinates 3,400 feet north and 10,350 feet east (mine grid co-ordinates) or Inspiration's grid co-ordinates of 12metres plus 99 metres north and 22 metres plus 61 metres east. The drill hole intersected the down dip and down plunge extension of the Langmuir No. 1 -- East zone, from approximately 6.7 metres to 16.46 metres below the 315-foot underground level on Section 3400N.
L105-1 confirmed previous historical drilling that indicated 2.47 per cent Ni over 40.5 feet (12.34 metres) in hole 76-9 and 0.943 per cent Ni over 17.5 feet (533 metres) and 1.735 per cent Ni over 60.0 feet (18.29 metres) in hole 30727 which were above L105-1 Z3 zone (from 123.33 metres to 136.23 metres).
The nickel-bearing sulphide mineralization, with estimations ranging from 5 per cent to 7 per cent fine-grained disseminations up to massive sulphides, is contained within serpentenized komatiitic ultramaftic extrusive flows with occasional spinifex texture.
The assaying technique used is the industry standard for base metal assaying, which uses nitric and hydrochloric acids that extracts nickel only from sulphide mineralization and not from nickel silicate minerals.
The assaying of split core samples was conducted by Swastika Laboratories, and included the insertion of blanks and standards. The qualified person in charge of the Langmuir project and the person who prepared the technical data in this release is Kian Jensen, BSc, PGeo (Ontario).
PTI-T NR today 92m at 6.67
Globe/CP say Patheon posts third quarter loss
2006-03-06 08:40 ET - In the News
The Globe and Mail reports in a Canadian Press dispatch Saturday a pack of troubles continued to plague Toronto drug maker Patheon in the first quarter. The unbylined item says the firm posted a big loss and its battered stock took a hit. The woes will not end for some time, Patheon said Friday, with lower growth expected for the near term. Patheon confirmed projections that production problems at its plants in Puerto Rico and elsewhere would hamper its bottom line. Patheon reported a loss of $11.5-million (U.S.) or 12.4 U.S. cents a share in the quarter. That compares with a profit of $6-million (U.S.) or 8.7 U.S. cents for the same period last year. Revenue rose 3 per cent to $157.9-million (U.S.), from $153.9-million (U.S.), below the company's expectations. Patheon shares fell 21 Canadian cents to $6.67 (Canadian).
New site I found for computer bargains & coupons
http://www.xpbargains.com/
DJE.V +.07 to 1.46
GNBT NR today 2.22
Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn(TM)
2006-03-03 08:45 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/03/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=111920&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product for the treatment of diabetes.
The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn(TM) with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn(TM) to be marketed and distributed in Canada.
"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn(TM) and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."
The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex website at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800)391-6755 and (416)364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212)732-4300
PTI.T NR today 92M at 6.88
Patheon loses $11.5-million (U.S.) in Q1 2006
2006-03-03 09:01 ET - News Release
Mr. Robert Tedford reports
PATHEON ANNOUNCES FIRST QUARTER RESULTS
Patheon Inc. has released its results for the first quarter ended Jan. 31, 2006. (All amounts are in U.S. dollars unless otherwise indicated.)
Highlights include:
revenues increased 3 per cent to $157.9-million;
revenues from Mova operations were $29.4-million compared with $23.9-million for five weeks a year ago. Revenues from other sites were $128.5-million compared with $130.0-million a year ago;
EBITDA (earnings before interest, taxes, depreciation and amortization) was $14.0-million compared with $21.6-million; the EBITDA margin was 8.9 per cent compared with 14.1 per cent;
the net loss (excluding the impact of one-time costs for debt prepayment charges and the write-off of deferred financing costs) was 5.8 cents per share, compared with net earnings of 10.6 cents per share a year ago;
the net loss for the quarter was $11.5-million, or 12.4 cents per share, compared with net earnings of $6.0-million or 8.7 cents per share a year ago.
"As previously announced, our first quarter results were weaker than anticipated," said Robert Tedford, chief executive officer, Patheon. "In addition to normal seasonality and holiday shutdowns associated with the first quarter, revenues and profitability were affected by difficulties with the production of Omnicef at our Carolina, Puerto Rico, facility, lower demand for over-the-counter manufacturing services, temporary production issues at our Swindon and Whitby sites, and client orders deferred to later quarters at our Monza facility. In our PDS business, North American revenue growth was slower than we expected, in part because of capacity constraints at our Toronto region site where several successful, newly launched Rx products are being manufactured."
Operating review
First quarter revenues increased 3 per cent to $157.9-million. Prescription (Rx) manufacturing revenues and pharmaceutical development services (PDS) revenues both increased by 5 per cent, offset by over-the-counter (OTC) revenues that declined by 10 per cent.
In Europe, year-over-year currency-adjusted revenue growth of 23 per cent (12 per cent as reported) was driven by Rx volumes at Swindon, U.K., and the two Italian sites, as well as PDS activities. Revenue growth in Europe was lower than anticipated due to the deferral of client orders to later quarters in 2006, temporary production issues at the Swindon facility and regulatory-related delays in the transfer of a new sterile product at the Monza site that have since been resolved.
"We are encouraged by the overall year-over-year improvement in operating performance at Swindon, continued strong demand for our specialized lyophilization services in Italy and the solid growth in our European PDS business," said Mr. Tedford. "We are also starting to see the benefits of carve-out initiatives in France and Italy, where two clients are transferring a range of products to our sites as they realign their own manufacturing networks."
In North America, revenues from the Puerto Rico operations were $29.4-million compared with $23.9-million for five weeks in the first quarter of 2005. Revenues in Puerto Rico were affected primarily by a decision taken by the company to voluntarily suspend production of Omnicef while it resolved issues identified in a warning letter from the U.S. Food and Drug Administration. Although production resumed in December, volumes were constrained by slower line speeds and lower yields. In addition, the validation of a third line was not completed until early February.
"With the new line now operational and other productivity improvement initiatives that we have put in place, we expect to achieve continuous improvements in run rates for this high-volume product beginning in the second quarter through to the end of 2006," said Mr. Tedford.
At other North American sites, commercial revenues were impacted by lower volumes at Whitby and at the Canadian OTC sites. Growth in PDS revenues was lower than expected due, in part, to the lack of available capacity at the Toronto region high-potency facility, which is currently manufacturing several newly launched Rx products. The latter issue is being addressed by internal transfers of products not requiring high-potency capabilities to other sites, including those in Puerto Rico, and by expanding PDS operations at other sites, most notably the company's Toronto York Mills facility.
EBITDA amounted to $14.0-million, a decrease of $7.6-million, or 35 per cent, from the first quarter of 2005. The EBITDA margin in the quarter was 8.9 per cent compared with 14.1 per cent a year earlier. The decline in the overall EBITDA margin was attributable to significantly lower capacity usage at Mova operations compared with the same period a year ago. The EBITDA margin for the other sites in the company's network was higher than a year ago.
Depreciation and amortization expense in the quarter was $9.8-million, compared with $7.8-million in the first quarter of 2005. Approximately $1.1-million of the increase reflects the inclusion of depreciation of Mova assets for a full quarter versus five weeks a year ago.
Amortization of intangible assets was $3.4-million, compared with $1.3-million last year, with the increase due to the inclusion of a full quarter of amortization relating to the Mova operations. Interest expense was $5.1-million, an increase of $2.8-million over last year, reflecting a full quarter of interest expense related to the additional debt associated with the Mova acquisition.
On Dec. 15, 2005, Patheon completed new credit facilities in North America in the total amount of $290.0-million to refinance existing debt of the company and its U.S. subsidiaries, including its subsidiaries in Puerto Rico. As a result of the refinancing, there was a charge during the first quarter of $1.6-million in connection with the cancellation and prepayment of certain credit facilities. The company also wrote off $6.3-million in related deferred financing costs.
The effective tax rate in the quarter was 8.8 per cent, compared with 21.5 per cent in the same period a year ago. The decrease reflects the impact of losses incurred by the Mova operations, which are at the lowest tax rate in the Patheon group.
The net loss in the first quarter of 2006, before one-time debt prepayment charges and the write-off of deferred financing costs of $6.2-million, was $5.3-million, or 5.8 cents per share, compared with net earnings of $7.3-million, or 10.6 cents per share last year. The net loss for the first quarter of 2006 was $11.5-million, or 12.4 cents per share, compared with net earnings of $6.0-million or 8.7 cents per share a year ago. First quarter net earnings last year included a one-time charge of $1.3-million, or 1.9 cents per share, for the write-off of deferred financing costs.
In the first quarter, cash provided by operating activities amounted to $7.8-million compared with $20.5-million in the same period a year ago. Capital expenditures in the quarter were $13.9-million, which included project-related expenditures in relation to the establishment of sterile cephalosporin lyophilization capacity at Swindon, U.K., and high-potency capabilities at Bourgoin-Jallieu, France. While additions to capital assets in the quarter exceeded cash from operating activities by $6.2-million, the company has received $9.6-million from a client in connection with the Swindon, U.K., expansion, which has been recorded as deferred revenues.
At quarter end, the company's consolidated interest-bearing debt to shareholders' equity was 52 per cent, compared with 67 per cent a year ago and 56 per cent at the end of the 2005 fiscal year. The improvement relative to the first quarter of 2005 reflects the repayments of long-term debt financed from the release of $22.8-million held in escrow in connection with the Mova acquisition during the third quarter of 2005, and the release of $7.8-million in restricted cash during the first quarter of 2006.
Outlook
"The impact of operating challenges in the first quarter on revenues and profitability will be difficult to overcome in the remainder of 2006," commented Mr. Tedford.
"While we continue to expect that the second half of the year will be better than the first half, overall growth will be lower than anticipated due to declines in North American base business that are more significant than usual," added Mr. Tedford.
"We are encouraged by the growth in our European operations, the success of our high-potency capabilities at our Toronto region site where a total of nine new products have been launched since 2001, as well as our continued success in developing our PDS pipeline," said Mr. Tedford. "At quarter end, we were providing development services for 152 projects, including six that are in line for regulatory approval.
"As a result of operating challenges in the first quarter together with lower-than-expected revenues in 2006, both EBITDA and net earnings will be lower than in fiscal 2005. We expect improved results in the second quarter, with further improvement in the second half.
"We continue to view 2006 as a transition year as we address the challenges in our Puerto Rico operations, complete the transfer of two groups of products to our Bourgoin and Italian operations, complete our new cephalosporin lyophilization facility in Swindon, and continue to develop additional PDS capacity both in existing facilities as well as in India.
"In addition to these specific initiatives, we have also engaged in a broader course of action focused on improving efficiency and reducing operating costs across the organization. This includes a global procurement program to consolidate and leverage our global purchasing power, and the implementation of companywide cost-saving programs."
Patheon will host a webcast conference call with financial analysts on its first quarter results on Friday, March 3, 2006, at 10 a.m. EST. Representing Patheon on the call will be: Robert Tedford, chief executive officer; Nick DiPietro, president and chief operating officer; and Rodger Roden, chief financial officer. Interested parties are invited to access the call live, in listen-only mode, via telephone, at 416-644-3426 or toll-free, at 1-800-814-4862 (please call between five and 15 minutes in advance). A live audio webcast, with a slide presentation, will be available on the company website. An archived version of the first quarter webcast will be available on the website for three months.
Patheon will hold its annual meeting of shareholders at 10:30 a.m. EST on Thursday, March 9, 2006, in the Queen's Park ballroom of the Park Hyatt Toronto, 4 Avenue Rd., Toronto, Ont., Canada. A live audio webcast, including the slide presentation by Patheon executives to shareholders and the subsequent question-and-answer period, will be available at the company website. An archived version of the webcast of the annual meeting of shareholders will be available on the company website for three months.
CONSOLIDATED STATEMENT
OF EARNINGS (LOSS)
Three months ended Jan. 31
(in thousands of U.S. dollars)
2006 2005
Revenues $157,944 $153,947
Operating expenses 143,932 132,300
-------- --------
Earnings before
the following 14,012 21,647
-------- --------
Depreciation and
amortization 9,811 7,819
Amortization of
intangible assets 3,423 1,280
Interest 5,103 2,333
Debt prepayment
charges 1,643 -
Amortization of
deferred financing
costs 325 577
Write-off of
deferred financing
costs 6,332 1,994
-------- --------
Earnings (loss)
before income taxes (12,625) 7,644
Provision for
(recovery of) income
taxes (1,115) 1,640
-------- --------
Net earnings (loss)
for the period $(11,510) $ 6,004
======== ========
Earnings (loss)
per share (cents)
Basic 12.4 8.7
Diluted 12.4 8.7
CONSOLIDATED STATEMENT OF
RETAINED EARNINGS
Three months ended Jan. 31
(in thousands of U.S. dollars)
2006 2005
Retained earnings,
beginning of the
year $98,250 $76,629
Net earnings (loss)
for the period (11,510) 6,004
------- -------
Retained earnings,
end of period $86,740 $82,633
======= =======
We seek Safe Harbor.
This is the address for Stockwatch .com they have all that you need and more.
http://new.stockwatch.com/swnet/default.aspx
ONC.T NR today 36m at 5.37
Oncolytics loses $12.78-million in 2005
2006-03-03 07:44 ET - News Release
Dr. Brad Thompson reports
ONCOLYTICS BIOTECH INC. REPORTS HIGHLIGHTS AND FINANCIAL RESULTS FOR 2005
Oncolytics Biotech Inc. has reported its financial results for the year ended Dec. 31, 2005.
"We are encouraged by the results we are observing and the progress we have made in both our preclinical and clinical programs," said Dr. Brad Thompson, president and chief executive officer of Oncolytics Biotech. "In 2005, we expanded our clinical program into the U.S., commenced our first co-therapy study in the U.K. and presented positive interim results from our first systemic administration study."
Selected highlights:
strengthened the financial base by raising net proceeds of $18.8-million to help finance the planned phase II program;
reported interim results from a phase I systemic administration trial in the United Kingdom that demonstrated Reolysin was well tolerated and can be delivered to and show activity in a variety of tumour types and locations in the body;
expanded the clinical program with the approval and commencement of enrolment for a phase I combination Reolysin/radiation trial in the U.K. and a phase I systemic delivery trial in the U.S.;
received clearance to commence a phase I/II recurrent malignant glioma (brain cancer) study in the U.S., while concluding enrolment in a phase I recurrent malignant glioma clinical trial in Canada;
presented promising preclinical research at two AACR conferences in the areas of immune interaction and co-therapy with existing chemotherapies and radiation;
appointed Dr. Karl Mettinger to the position of chief medical officer;
expanded the company's intellectual property portfolio with the issue of its first four Canadian patents and a second European patent in 2005, and a 14th United States patent in early 2006; and,
announced in January, 2006, that the U.S. National Cancer Institute is seeking proposals to conduct a phase II systemic administration trial for patients with melanoma, and a phase I/II systemic and intraperitoneal trial for patients with ovarian cancer.
STATEMENT OF (LOSS) AND (DEFICIT)
Year ended Dec. 31
2005 2004
Revenue
Rights
revenue $ - $ -
Interest
income $ 783,456 $ 699,757
------------ ------------
783,456 699,757
------------ ------------
Expenses
Research and
development 9,308,977 7,107,998
Operating 3,084,897 2,803,669
Stock-based
compensation 64,104 2,668,570
Foreign
exchange
loss 253,608 358,068
Amortization --
intellectual
property 786,459 686,717
Amortization
#NAME?
assets 69,532 65,039
------------ ------------
13,567,577 13,690,061
------------ ------------
Loss before
the following 12,784,121 12,990,304
Gain on
sale
of BCY
LifeSciences
Inc. (765) (34,185)
Loss on
sale of
Transition
Therapeutics
Inc. - -
------------ ------------
Loss before
taxes 12,783,356 12,956,119
Capital tax
(recovery) (1,525) -
Future income
tax recovery - -
------------ ------------
Net loss for
the year $ 12,781,831 $ 12,956,119
Deficit,
beginning
of year 37,950,711 24,994,592
------------ ------------
Deficit,
end of year $ 50,732,542 $ 37,950,711
============ ============
Basic and
diluted
(loss)
per share $ (0.39)$ (0.45)
We seek Safe Harbor.
PLE.V Interesting - In for a few
News out for PLE.V
NR out for PLE.V
MPH.T unusual action something is coming??
MPH.T something is coming???
NRI.t NR today 123M at .57
Nuvo Research's Pennsaid topic of research paper
2006-03-02 09:46 ET - News Release
Dr. Henrich Guntermann reports
NUVO ANNOUNCES PENNSAID(R) DATA PUBLISHED IN THE JOURNAL OF RHEUMATOLOGY
Nuvo Research Inc. advises of the publication of a research paper in the March 1, 2006, issue of the Journal of Rheumatology entitled "Pennsaid Therapy for Osteoarthritis of the Knee: A Systemic Review and Metaanalysis of Randomized Controlled Trials." The author, Dr. Tanveer E. Towheed, MD, associate professor of medicine and of community health and epidemiology in the department of medicine at Queen's University, concluded that Pennsaid is an effective topical non-steroidal anti-inflammatory (NSAID) in patients with osteoarthritis of the knee and that, apart from minor localized skin reactions, Pennsaid was as safe as the vehicle control placebo.
"We are pleased to see the publication of this independent review, in which the author notes the high quality of our clinical trials and reaffirms the efficacy and safety of Pennsaid in the treatment of osteoarthritis," said Dr. Henrich Guntermann, Nuvo's president and chief executive officer.
The objective of the paper was to systematically review four randomized controlled trials evaluating Pennsaid treatment of patients with osteoarthritis of the knee. As reported in the paper, Pennsaid treatment resulted in a significant difference in favour of Pennsaid for pain, stiffness, and physical function and patient global assessment measured by the Western Ontario and McMaster Osteoarthritis Index (WOMAC), when compared with vehicle control placebo. Pennsaid was as safe as vehicle control placebo, with the only exception that it was more likely to result in minor skin dryness at the site of application. In a head-to-head equivalence trial using the WOMAC subscales over 12 weeks, Pennsaid was as effective as oral diclofenac, but was much better tolerated.
Pennsaid is a topical non-steroidal anti-inflammatory (NSAID) used for the treatment of osteoarthritis and is currently approved for sale in Canada and several European countries.
We seek Safe Harbor.
DDS.T NR today 43M at 8.44
Labopharm appoints Costa to board
2006-03-02 08:29 ET - News Release
Mr. James Howard-Tripp reports
LABOPHARM APPOINTS SANTO J. COSTA TO BOARD OF DIRECTORS
Santo J. Costa has been appointed to Labopharm Inc.'s board of directors.
"Sandy brings to Labopharm's board more than 30 years of experience in the pharmaceutical industry in senior operating manager, senior counsel and senior executive roles," said James R. Howard-Tripp, president and chief executive officer, Labopharm. "We look forward to his guidance and counsel as we commercialize our once-daily tramadol product in key markets around the world and pursue our long-term vision of building a fully integrated, international specialty pharmaceutical company."
Previously, Mr. Costa held the role of president and chief operating officer of Quintiles Transnational Corporation (Nasdaq: QTRN), an international provider of a full range of pharmaceutical product development and commercialization activities, from early compound development, laboratory services and regulatory submission through sales and marketing. Mr. Costa joined Quintiles at the time of its initial public offering and, during his tenure, oversaw the successful integration of more than 40 acquisitions. During that same period, Quintiles's annual revenue grew from $90-million to $1.6-billion and its employee base grew from 1,000 to 20,000. Prior to joining Quintiles, Mr. Costa held the positions of general counsel and senior vice-president administration with Glaxo Inc. (NYSE: GSK), U.S. Area Counsel with Merrell Dow Pharmaceuticals and Counsel, Food & Drug with Norwich Eaton Pharmaceuticals. Mr. Costa is currently Of Counsel with Maupin Taylor P.A. of Raleigh, N.C., specializing in corporate law for health care companies.
Mr. Costa currently serves as director of a number of health sciences companies, including NPS Pharmaceuticals, Inc. (Nasdaq: NPSP), CV Therapeutics, Inc. (Nasdaq: CVTX), Digiscripts and Constella Group, and is chairman of NeuroMedix Inc. (TSX-V: NMX). He also sits on the board of advisers of the North Carolina Outward Bound School, the Duke Brain Tumor advisory committee, the Duke University Medical Center board of visitors and the Duke Cancer Patient Support Program board. Mr. Costa is an adjunct professor in the clinical research program at the Campbell University School of Pharmacy. Mr. Costa holds a BS in pharmacy and a JD, both from St. John's University. He is a member of the North Carolina Bar Association, the New York Bar and the Ohio Bar.
We seek Safe Harbor.
Deadly bird flu strain found in cat in Germany
By David Rising, Germany
Published: 28 February 2006
The H5N1 strain of bird flu was confirmed today in a cat in Germany, the first time it has been positively identified in a mammal in Europe, the World Health Organization said.
The cat was found dead over the weekend on the Baltic Sea island of Ruegen, where most of Germany's more-than 100 cases of H5N1-infected wild birds have been found, said Thomas Mettenleiter, leader of the Friedrich Loeffler institute lab.
Maria Cheng, a WHO spokeswoman in Geneva, said it was the first time she knows of that an animal other than a bird has been infected in Europe. She noted that tigers and leopards were infected by H5N1 in Thailand, where they were fed on chicken carcasses in a zoo.
In addition, bird flu infections were confirmed in January in humans in the Asian part of Turkey. Twenty-one people in the country tested positive for the H5N1 strain. Four of those victims, all children, died.
It is not clear whether cats can pass the disease to humans, Cheng said.
"We know that mammals can be infected by H5N1, but we don't know what this means for humans."
Scientists are concerned that H5N1 could mutate into a form that is transmitted easily among humans, which could lead to a pandemic.
Mettenleiter said there are no known cases of the virus moving from cats to humans, but nonetheless cautioned pet owners on Ruegen to keep their cats inside for the time being.
"An infection of humans, which theoretically cannot be ruled out, could probably only occur with very intimate contact to infected animals," Mettenleiter said.
In addition to the large cats infected in Thailand, three house cats were found to be infected with the virus in February 2004 outside Bangkok. In that case, officials said one cat had eaten a dead chicken on a farm where there was a bird flu outbreak and it appeared to have spread to the others.
Also today in Germany the H5N1 strain of the bird flu virus was detected in wild birds in Bavaria, making it the fifth German state to report cases.
The Friedrich Loeffler institute determined that two wild birds found in the southern state tested positive for the strain, the state said.
The first cases of H5N1 were found on Ruegen in mid-February.
Maria Cheng, a World Health Organisation spokeswoman in Geneva, said it is the first time she knows of an animal other than a bird being infected in Europe, while noting tigers and leopards were infected by H5N1 in Thailand, where they were fed on chicken carcasses in a zoo.
It is not clear whether cats can pass the disease on to humans, Cheng said. "We know that mammals can be infected by H5N1, but we don't know what this means for humans."
The H5N1 strain of bird flu was confirmed today in a cat in Germany, the first time it has been positively identified in a mammal in Europe, the World Health Organization said.
The cat was found dead over the weekend on the Baltic Sea island of Ruegen, where most of Germany's more-than 100 cases of H5N1-infected wild birds have been found, said Thomas Mettenleiter, leader of the Friedrich Loeffler institute lab.
Maria Cheng, a WHO spokeswoman in Geneva, said it was the first time she knows of that an animal other than a bird has been infected in Europe. She noted that tigers and leopards were infected by H5N1 in Thailand, where they were fed on chicken carcasses in a zoo.
In addition, bird flu infections were confirmed in January in humans in the Asian part of Turkey. Twenty-one people in the country tested positive for the H5N1 strain. Four of those victims, all children, died.
It is not clear whether cats can pass the disease to humans, Cheng said.
"We know that mammals can be infected by H5N1, but we don't know what this means for humans."
Scientists are concerned that H5N1 could mutate into a form that is transmitted easily among humans, which could lead to a pandemic.
Mettenleiter said there are no known cases of the virus moving from cats to humans, but nonetheless cautioned pet owners on Ruegen to keep their cats inside for the time being.
"An infection of humans, which theoretically cannot be ruled out, could probably only occur with very intimate contact to infected animals," Mettenleiter said.
In addition to the large cats infected in Thailand, three house cats were found to be infected with the virus in February 2004 outside Bangkok. In that case, officials said one cat had eaten a dead chicken on a farm where there was a bird flu outbreak and it appeared to have spread to the others.
Also today in Germany the H5N1 strain of the bird flu virus was detected in wild birds in Bavaria, making it the fifth German state to report cases.
The Friedrich Loeffler institute determined that two wild birds found in the southern state tested positive for the strain, the state said.
The first cases of H5N1 were found on Ruegen in mid-February.
Maria Cheng, a World Health Organisation spokeswoman in Geneva, said it is the first time she knows of an animal other than a bird being infected in Europe, while noting tigers and leopards were infected by H5N1 in Thailand, where they were fed on chicken carcasses in a zoo.
It is not clear whether cats can pass the disease on to humans, Cheng said. "We know that mammals can be infected by H5N1, but we don't know what this means for humans."
NVAX NR today opened at 6.0325
Novavax Announces Fourth Quarter and Year-End 2005 Financial Results
2006-03-01 08:00 ET - News Release
MALVERN, Pa., March 1 /PRNewswire-FirstCall/ -- Novavax, Inc. today announced its fourth quarter and year-end 2005 financial results.
Recent Significant Events at Novavax include:
-- Completed $38.0 million in equity capital raises at $4.30-$4.35 per
share (November 2005/February 2006)
- Total of $42.0 million of new equity capital raised within last
twelve months
-- Completed License Agreement on ESTRASORB(R) with Esprit Pharma Inc. for
North American distribution (October 2005)
- Minimum $12.5 million in mandatory payments over twelve months
(received $10.0 million in 2005 and $2.5 million due in October 2006)
- Double digit royalty on all ESTRASORB sales
- Significant future milestone payments
- Novavax maintains product manufacturing, and international markets
outside of North America
-- Converted $6.0 million of outstanding convertible notes to equity
(October 2005)
- Reduced convertible notes outstanding to $29.0 million
- Reduced annual interest expense by $285,000
- Remaining bondholders cannot "Put" remaining convertible notes to the
Company until July 2007
-- Expanded the Vaccine Initiative
- Research collaboration initiated with the University of Pittsburgh
School of Medicine on efficacy seasonal and pandemic influenza.
(February 2006)
- Formed strategic alliances with Wave Biotech and Pacific GMP on the
development of a commercial scale manufacturing and production
process for vaccines. (September 2005/February 2006)
- Formed Special Governmental Relations Committee of the Board.
(December 2005)
-- Filed a new $100.0 Million Shelf Registration Statement (December
2005)
-- Nominated two new experienced Board Members from within the bio-
pharmaceutical industry.
Commenting on the fourth quarter and year-end 2005 operating results, Dr. Rahul Singhvi, President and Chief Executive Officer, stated, "Novavax continued its transformation into a new, dynamic company focused on development of new important products in the fourth quarter of 2005. The licensing of North American marketing rights of Estrasorb to Esprit Pharma was critical to our business plan. We assumed a leadership position in addressing the global pandemic influenza threat by leveraging our virus-like particle (VLP), Novasome adjuvants, and portable manufacturing technologies. We now believe we have the necessary financial and human resources to develop a vaccine against H5N1 and other strains of avian and seasonal influenza vaccines and we look forward to reporting our progress on these programs in the near future."
Fourth Quarter Financial Results
Total revenues for the fourth quarter ended December 31, 2005 were $2.2 million compared with total revenues of $2.0 million for the same period last year. The increase was due to a $1.0 million license payment offset by decreases in product sales due to the sale or license of the Company's vitamin, AVC and ESTRASORB products in September and October 2005. For the twelve-month periods ended December 31st, in 2005, total revenues were $7.4 million compared with $8.3 million in 2004. Of the total decrease in revenues, product sales accounted for $1.8 million, due to the sales and license of products, partially offset by a $0.9 million increase, in royalties, milestone and licensing fees.
Cost of products sold for the three-month period ended December 31, 2005 was reduced significantly to $717 thousand compared with $1.4 million for the three-month period ended December 31, 2004, primarily due to the sale of the majority of the Company's product lines. In the three month period ended December 31, 2005 the Company also took a $1.5 million charge to write down ESTRASORB inventory to values which reflected future selling cost. Cost of products sold for the twelve month period, which includes fixed idle capacity costs at our manufacturing facility, increased to $5.8 million in 2005, compared to $3.5 million in 2004, a 66% increase. Of the $5.8 million costs of products sold for 2005, $3.2 million was due to idle plant capacity costs at our manufacturing facility compared to $0.7 million in 2004. The remaining $2.6 million increase was primarily due to ESTRASORB, which accounted for 45% of net product sales in 2005, as compared to 28% of net product sales in 2004.
Research and development costs for the three-month period ended December 31, 2005, were $1.3 million compared to $1.5 million for the three-month period ended December 31, 2004. For the full year research and development costs decreased from $7.4 million in 2004 to $5.1 million in 2005. The decrease of $2.3 million or 31% was due to manufacturing start-up costs in 2004 being accounted for in the research and development category until production began in April 2004. We expect research and development costs to increase in 2006 as we progress on the development of other products in our pipeline, primarily related to vaccine research and development.
Selling and marketing costs were reduced to $89 thousand for the three- month period ended December 31, 2005, compared with $6.3 million for the same period last year. The decrease of $6.2 million was primarily due to the prior investment in the marketing launch of ESTRASORB in 2004, as well as elimination of our sales force over the past year and the decision to discontinue any further marketing efforts solely within our Company. Selling and marketing expenses were $6.9 million for the twelve month period ended December 31, 2005, compared with $23.6 million for the same twelve-month period last year. The $16.7 million decrease was primarily due to the significant marketing investment made in 2004 for the initial launch of ESTRASORB as well as our business strategy of transitioning to our core competency of new product development.
Total general and administrative costs were $2.0 million for the three- month period ended December 31, 2005, compared with $2.7 million for the three-month period ended December 31, 2004. The reduction in general administrative costs during this period of $0.7 million was due to reductions in various categories of expenses, including accounting, consulting, investor relations, and salary expense. Total general and administrative costs were $8.1 million for the twelve-month period ended December 31, 2005, compared with $8.7 million for the similar period in 2004.
In October 2005, the Company entered into License and Supply Agreements for its primary product, ESTRASORB. In consideration for the rights granted, the Company was paid $10.0 million in the fourth quarter of 2005. A minimum amount of another $2.5 million will be paid during the fourth quarter 2006, along with other contingency royalties and milestone payments. As part of this transaction the Company also wrote off $2.2 million which represented the remaining net balance of its intangible asset for ESTRASORB. The Company incurred $0.2 million of fees related to this transaction and recorded a gain of $10.1 million during the fourth quarter of 2005.
For the three-month period ended December 31, 2005, the Company had a net profit of $6.2 million, or $0.13 per share, compared with a net loss of $10.3 million, or ($0.26) per share, for the same three-month period last year. For the twelve-month period ended December 31, 2005, the Company had a net loss of $11.2 million, or ($0.26) per share, compared with a net loss of $25.9 million, or ($0.70) per share for the similar 2004 period.
As of December 31, 2005, the Company had $31.9 million in cash and cash- equivalents compared with $17.9 million at December 31, 2004. The February 2006 equity offering, with gross proceeds of $20.0 million, adds to this year end balance. In November 2005, the Company also completed an equity offering of 4,186,047 shares of common stock at $4.30 per share for gross proceeds of $18.0 million. The equity raised in November 2005 and February 2006 were both issued pursuant to existing "shelf" registration statements.
Conference Call
The Company will hold an investor conference call to discuss its financial results at 10:00 a.m. ET on March 1, 2006. The call will be hosted by Mr. Gary C. Evans, Chairman of the Board and Dr. Rahul Singhvi, President and CEO of Novavax. Other participants on the call will include senior management of Novavax. A question and answer session will follow the financial results overview. The dial in number for the conference call is (866) 356-3093, pass code 67425359.
A live audio webcast and presentation of the conference call will be available through http://www.novavax.com. Please connect to this website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. A replay of the webcast will be available for 90 days starting on March 1, 2006 at http://www.novavax.com. A replay of the conference call will also be available by telephone on March 1, 2006 through June 1, 2006. To access the replay, dial (888) 286-8010 and enter pass code 63645862 followed by the number sign.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. These include the Company's virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies. Novavax, Inc. is also a product development company focused on the research, development and commercialization of new products utilizing its proprietary drug delivery and biological technologies for large and growing markets. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB. In addition to MNP, Novavax drug delivery technologies include Novasomes(R) (paucillamellar non- phospholipid liposomes) and Sterisomes(R) (subcutaneous depot injection).
NOVAVAX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share information)
Unaudited
Three-months ended Year ended
December 31, December 31, December 31, December 31,
2005 2004 2005 2004
Revenues:
Net product sales $641 $ 2,207 $ 4,549 $6,397
Contract research &
development 562 (161) 1,798 1,738
Royalties, milestone
and licensing fees 1,041 - 1,041 125
Total revenues 2,244 2,046 7,388 8,260
Operating costs and expenses:
Cost of products sold 717 1,362 5,791 3,490
Excess inventory costs
over market 1,519 - 1,519 -
Research and
development 1,315 1,541 5,075 7,369
Selling and
administrative 89 6,327 6,920 23,588
General and
administrative 2,005 2,724 8,114 8,716
Facility exit costs - - 105 723
Gain on sales of
product assets (10,109) - (10,965) -
Gain on redemption
of debt - - - (11,162)
Total operating
costs and expenses (4,464) 11,954 16,559 32,724
Gain/(Loss) from
operations 6,708 (9,908) (9,171) (24,464)
Interest expense, net (553) (450) (2,003) (1,526)
Other income - 70 - 70
Net gain/(loss) $ 6,155 $(10,288) $(11,174) $(25,920)
Basic and diluted
gain/(loss) per share $0.13 $ (0.26) $ (0.26) $(0.70)
Basic and diluted
weighted average
number of common
shares
outstanding 47,887,656 39,553,876 42,758,302 36,926,034
Selected Balance Sheet Data
(in thousands)
As of December As of December
31, 2005 31, 2004
Cash and cash equivalents $ 31,893 $ 17,876
Total current assets $ 37,611 $ 23,937
Working capital $ 32,735 $ 15,361
Total assets $ 84,382 $ 77,993
Long term obligations $ 29,678 $ 35,970
Stockholders' equity $ 49,652 $ 33,281
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2004 and quarterly reports on Form 10Q for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at http://www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax, Inc.,
+1-484-913-1213, khamilton@novavax.com
Web site: http://www.novavax.com/